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EP2731562B2 - Systèmes intra-utérins, dispositifs d'introduction de dispositif intra-utérin (iud), et trousses pour ceux-ci - Google Patents
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EP2731562B2 - Systèmes intra-utérins, dispositifs d'introduction de dispositif intra-utérin (iud), et trousses pour ceux-ci - Google Patents

Systèmes intra-utérins, dispositifs d'introduction de dispositif intra-utérin (iud), et trousses pour ceux-ci Download PDF

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Publication number
EP2731562B2
EP2731562B2 EP12811921.1A EP12811921A EP2731562B2 EP 2731562 B2 EP2731562 B2 EP 2731562B2 EP 12811921 A EP12811921 A EP 12811921A EP 2731562 B2 EP2731562 B2 EP 2731562B2
Authority
EP
European Patent Office
Prior art keywords
sheath
slider
iud
insertion device
elongated
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP12811921.1A
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German (de)
English (en)
Other versions
EP2731562A2 (fr
EP2731562B1 (fr
EP2731562A4 (fr
Inventor
Rob Deckman
Richard E. Repp
Curt GUYER
Justin WESTENDORF
Timothy Parmer
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Medicines360
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Medicines360
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Publication date
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Application filed by Medicines360 filed Critical Medicines360
Publication of EP2731562A2 publication Critical patent/EP2731562A2/fr
Publication of EP2731562A4 publication Critical patent/EP2731562A4/fr
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Publication of EP2731562B1 publication Critical patent/EP2731562B1/fr
Publication of EP2731562B2 publication Critical patent/EP2731562B2/fr
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F6/00—Contraceptive devices; Pessaries; Applicators therefor
    • A61F6/06—Contraceptive devices; Pessaries; Applicators therefor for use by females
    • A61F6/14—Contraceptive devices; Pessaries; Applicators therefor for use by females intra-uterine type
    • A61F6/142—Wirelike structures, e.g. loops, rings, spirals
    • A61F6/144—Wirelike structures, e.g. loops, rings, spirals with T-configuration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F6/00—Contraceptive devices; Pessaries; Applicators therefor
    • A61F6/06—Contraceptive devices; Pessaries; Applicators therefor for use by females
    • A61F6/14—Contraceptive devices; Pessaries; Applicators therefor for use by females intra-uterine type
    • A61F6/18—Inserters or removers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F6/00—Contraceptive devices; Pessaries; Applicators therefor
    • A61F6/06—Contraceptive devices; Pessaries; Applicators therefor for use by females
    • A61F6/08—Pessaries, i.e. devices worn in the vagina to support the uterus, remedy a malposition or prevent conception, e.g. combined with devices protecting against contagion
    • A61F6/12—Inserters or removers

Definitions

  • the stop members ensure that the front edge of the protective tube is stopped in a configuration in which the hemispherical tips of the wings of the transverse member of a T-shaped IUD remain partly uncovered by the protective tube, but the wings nevertheless remain pressed against each other.
  • the elongated guide can further be configured to comprise one or more cavities on one or more of the proximal end of the elongated guide and the distal end of the elongated guide wherein the one or more cavities are adapted and configured to house at least a portion of the movable sheath slider.
  • the devices further comprise a string control slider.
  • the string control slider can be adaptable and configurable to securely move within the elongated guide.
  • the elongated sheath slider and the string control slider are adapted and configured to operate at least one of simultaneously and independently within one or more elongated guides.
  • the distal end 20 of the sheath 332 is configurable such that it forms a rounded tip which can flare open when the IUD positioned within the sheath is advanced beyond its distal end (e.g., has an aperture of a first diameter when the IUD is fully positioned within the sheath, and an aperture of a second, larger, diameter when the IUD is advanced distally beyond the tip of the sheath).
  • FIGS. 4A-4C depict a cross-section of the IUD 402 in combination with an insertion device 400 during transition from a first phase (1) to a second phase (2) of IUD insertion, along cross-section D-D of FIG. 3B .
  • the arms 406a, 406b of the IUD 402 have been advanced distally (i.e., towards the distal end 20 ) and out of the sheath 432, which has a proximal end and a distal end and a lumen extending between the proximal end and the distal end, which allows the arms 406a, 406b to extend radially away from a central axis x.
  • FIGS. 4D-4F illustrate positioning of an insertion device 400 during a second phase of IUD insertion. In phase 2, the IUD 402 is partially deployed from the sheath 432 as shown in FIG. 4B .
  • the present disclosure describes insertion devices comprising one or more features for controlling a longitudinal position of an IUD throughout various phases of the IUD insertion procedure.
  • the insertion devices are adaptable and configurable to include an IUD insertion device comprising an elongated inner member and an elongated sheath at least partially encasing or surrounding the elongated inner member, wherein the inner member and sheath are configurable to engage in translation movement relative to one another along the longitudinal axis.
  • the IUD insertion devices moreover can accommodate a variety of IUD configurations.
  • Position control features of the present disclosure are soft motion control features which provide a soft stop during insertion device operation and merely impede or interrupt the sliding movement of the slider along the elongated guide, thereby contributing to a smooth, uninterrupted sliding motion.
  • the features can also include "hard stop” features which prohibit further movement of the slider in an undesired direction.
  • the force limiting feature prevents the slider from continuing motion in a distal (forward) direction when the force limiting feature(s) are engaged. Without the force limiting feature, the slider would continue distal (forward) movement.
  • Such a soft motion control feature prevents undesirable movement of the insertion device during the insertion procedure and promotes smooth user movements without disruptions caused by components of the insertion device contacting one another. Additionally, the alignment or coinciding of the slider and housing features can provide a signal to the user which indicates that the IUD is in the proper location corresponding to the corresponding procedural step.
  • the insertion device 1300 is configurable to include a bilateral configuration, wherein the sliders 1342, 1346 are accessible from either the top 30 (upper) or bottom 40 (lower) face or surface of the handle 1335.
  • the telescoping slider configuration allows for left-handed or right-handed user operation without the need for a bilateral configuration with slider control features on both the top and bottom of the handle/housing.
  • the sheath slider 1542 and string control slider 1546 are in a proximal position along the longitudinal axis of the elongated guide 1540.
  • a second sheath control slider surface 1542b abuts a proximal elongated guide surface 1540b.
  • the insertion device includes a slider 1642 positioned within a elongated guide 1640 which controls a linkage system 1650.
  • the configurations illustrated in FIGS. 16A-C are configurable to reduce an overall travel required by the user to achieve the various positions during use of the device.
  • a travel multiplier can be achieved such that a given user movement is magnified and thus requires less actual movement by the user on the slider.
  • the movement achieved in the handle is not 1:1 of the movement achieved at the distal end of the device.
  • the insertion device 1900 includes at least one gear or rack 1957 positioned within the handle 1935 housing attached to the lever 1942.
  • the gear 1957 moves a ratchet 1958 attached to the sheath 1932, whereby the gear 1957 moves the sheath proximally.
  • the motion control features are arrangeable such that the motion control features are aligned in a first position and then misaligned in a second position which is achievable upon rotating one or more of the plunger and sheath relative to one another, thereby allowing the IUD and plunger to be loaded into the sheath by first rotating the components, then sliding the plunger motion control features past the sheath motion control features, and finally rotating the components again to realign the plunger and sheath motion control features so that they are aligned during the insertion procedure.
  • the IUD can be loaded into an opening in the housing/handle or the side wall of the sheath, as discussed in further detail below.
  • the insertion devices are also configurable to include a sheath 2432 having a tapered or rounded distal end or tip 2432t , wherein the cross-section, or outer diameter, D, of the insertion device sheath decreases from a proximal value towards the distal end or tip of the insertion device, as illustrated in FIGS. 24A-24G .
  • the sheath tip 2432t is tapered or taperable toward the distal end of the sheath 2432, as illustrated in FIGS. 24A-24B .
  • the thickness T of the sheath 2432 wall can also be minimized at the distal-most end of the sheath 2432 to reduce the impact of the sheath wall thickness on the patient.
  • the inner sheath and/or the outer sheath is configurable to comprise the sheath tip 2432t.
  • the interface i between the sheath and cap of FIG. 24E , or between the inner and outer sheaths of FIG. 24F is a seamless interface which will not pinch, scratch, bind or otherwise harm the patient during the insertion procedure.
  • a seamless interface is achievable by matching the outer diameter of both components at the interface, i , e.g., matching the outer diameters of the sheath 2432 and sheath cap 2432c at the interface i shown in FIG.
  • the housing or string locking feature 2648 and/or the string unlocking feature 2649 can include an angled or tilted surface, whereby a surface of the string unlocking feature 2649 contacts a surface of the string locking feature 2648 when the strings are locked, and the surfaces are not in contact when the strings are unlocked.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Reproductive Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)
  • Surgical Instruments (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Claims (13)

  1. Dispositif d'insertion (800, 1300, 1400) pour un DIU, le dispositif d'insertion comprenant :
    une gaine allongée (832, 1332, 1432) ayant une extrémité proximale et une extrémité distale et une lumière s'étendant entre l'extrémité proximale et l'extrémité distale ;
    un élément intérieur allongé (834), ayant une extrémité proximale et une extrémité distale, pouvant être disposé dans la lumière de la gaine allongée (832, 1332, 1432) ;
    une interface utilisateur positionnée de manière proximale (835, 1335, 1435), dans lequel l'interface utilisateur positionnée de manière proximale comprend en outre un boîtier ayant un ou plusieurs guides allongés (840, 1340, 1440) formés au moins partiellement dans celui-ci et le long d'au moins une partie d'une longueur de celui-ci ; et
    un coulisseau de gaine mobile (842, 1342, 1442) en communication avec la gaine allongée, dans lequel le coulisseau de gaine mobile est adaptable et configurable pour se déplacer en toute sécurité dans le guide allongé et dans lequel en outre le coulisseau de gaine mobile commande le mouvement axial de la gaine allongée, dans lequel le guide allongé comprend en outre une ou plusieurs caractéristiques de commande de mouvement sur sa longueur et dans lequel l'une ou les plusieurs caractéristiques de commande de mouvement comprennent au moins une caractéristique de limitation de force (844) configurable pour limiter une quantité de force appliquée sur le coulisseau de gaine mobile, et
    caractérisé en ce que
    l'une ou les plusieurs caractéristiques de commande de mouvement sont adaptées pour fournir une rétroaction tactile.
  2. Dispositif d'insertion selon la revendication 1, dans lequel l'une ou les plusieurs caractéristiques de commande de mouvement sont sélectionnées parmi le groupe comprenant des cliquets, des encoches, des rainures, des protubérances, des languettes, des arêtes, des rebords, des volets, des guidages, des éléments flexibles, des contours, des courbes et des formes.
  3. Dispositif d'insertion selon la revendication 1, dans lequel le guide allongé :
    a une longueur, une largeur et une profondeur, et en outre dans lequel la largeur du guide allongé est au moins l'une d'une longueur variable le long et d'une largeur étagée choisie parmi deux ou plusieurs d'une première largeur et d'une deuxième largeur ; ou
    a un profil en plan choisi parmi une forme rectangulaire, une forme de S, une forme de C, une forme de U, une forme de W, une forme circulaire, une forme semi-circulaire et une forme ovale ; ou
    comprend en outre une ou plusieurs cavités (1045, 1345, 1445a, 1445b) sur une ou plusieurs parmi l'extrémité proximale du guide allongé et l'extrémité distale du guide allongé, dans lequel l'une ou les plusieurs cavités sont adaptées et configurées pour loger au moins une partie du coulisseau de gaine mobile.
  4. Dispositif d'insertion selon la revendication 1, dans lequel le coulisseau de gaine comprend un ou plusieurs profils de surface adaptés et configurés pour compléter mécaniquement l'une ou les plusieurs caractéristiques de commande de mouvement, facultativement dans lequel l'un ou les plusieurs profils de surface du coulisseau de gaine sont sélectionnés parmi le groupe comprenant une ou plusieurs de chacune de surfaces non planes, de surfaces courbes et de surfaces angulaires.
  5. Dispositif d'insertion selon la revendication 1, dans lequel le boîtier et le coulisseau de gaine comprennent en outre une ou plusieurs surfaces d'alignement (1044a, 1042b), dans lequel l'une ou les plusieurs surfaces d'alignement du boîtier sont adaptées et configurées pour compléter mécaniquement l'une ou les plusieurs surfaces d'alignement de la gaine.
  6. Dispositif d'insertion selon la revendication 5, dans lequel :
    une première surface d'alignement de coulisseau de gaine s'aligne avec une première surface d'alignement de boîtier à une première position le long de la longueur du guide allongé ; ou
    l'une ou les plusieurs surfaces d'alignement de coulisseau de gaine et l'une ou les plusieurs surfaces d'alignement de boîtier sont sélectionnées parmi le groupe comprenant une surface incurvée, une surface angulaire et une surface inclinée.
  7. Dispositif d'insertion selon la revendication 1, comprenant en outre un coulisseau de commande de cordon (1046, 1346, 1446), facultativement dans lequel le coulisseau de commande de cordon est adaptable et configurable pour se déplacer en toute sécurité dans le guide allongé.
  8. Dispositif d'insertion selon la revendication 1, comprenant en outre un coulisseau de commande de cordon, dans lequel :
    le coulisseau de gaine allongé et le coulisseau de commande de cordon sont adaptés et configurés pour fonctionner au moins simultanément et indépendamment dans un ou plusieurs guides allongés ; ou
    le coulisseau de gaine et le coulisseau de commande de cordon sont mobiles de manière télescopique le long d'au moins une première partie du guide allongé, et en outre dans lequel le coulisseau de gaine et le coulisseau de commande de cordon sont configurables de sorte qu'au moins un parmi le coulisseau de gaine et le coulisseau de cordon entoure partiellement le coulisseau restant ; ou
    le coulisseau de gaine et le coulisseau de commande de cordon sont en outre configurables pour comprendre une ou plusieurs surfaces verticales, dans lequel l'une ou les plusieurs surfaces verticales sont sélectionnées parmi le groupe comprenant une première surface verticale de coulisseau de gaine, une seconde surface verticale de coulisseau de gaine, une première surface verticale de coulisseau de commande de cordon, et une seconde surface verticale de commande de cordon, dans lequel une ou plusieurs des surfaces verticales sont configurées pour former une surface adjacente alignée à une ou plusieurs positions le long de la longueur du guide allongé ; ou
    le coulisseau de gaine et le coulisseau de commande de cordon ont une largeur combinée inférieure ou égale à au moins un parmi 0,75 pouce (19 mm), 0,7 pouce (17,8 mm), 0,5 pouce (12,7 mm), 0,35 pouce (8,9 mm), ou 0,25 pouce (6,3 mm).
  9. Dispositif d'insertion selon la revendication 1, dans lequel le dispositif d'insertion est configurable pour recevoir un DIU dans l'extrémité distale de la lumière de la gaine allongée, comprenant en outre au moins une caractéristique de verrouillage de cordon (1346) adaptable et configurable pour fixer un ou plusieurs composants de cordon du DIU.
  10. Dispositif d'insertion selon la revendication 9, dans lequel l'au moins une caractéristique de verrouillage de cordon comprend un ou plusieurs parmi une fente, un organe de serrage, une cale, une pince, un ressort ou des dents, facultativement dans lequel, lorsque la caractéristique de verrouillage de cordon comprend une fente, la caractéristique de déverrouillage de cordon comprend un élément mobile qui pousse l'un ou les plusieurs cordons hors de la fente pour déverrouiller l'un ou les plusieurs cordons.
  11. Dispositif d'insertion selon la revendication 1, dans lequel l'extrémité distale de la gaine allongée a une point atraumatique choisie parmi le groupe comprenant une pointe arrondie et une pointe effilée ;
    et facultativement l'extrémité distale de la gaine allongée
    a un diamètre extérieur d'environ 3 mm à 5 mm ;
    a un diamètre extérieur qui est égal ou inférieur à 80 %, 50 %, 30 % du diamètre extérieur de l'extrémité proximale de la gaine allongée ;
    un diamètre extérieur qui est inférieur à la dimension transversale maximale d'un DIU positionnable dans la lumière de la gaine allongée ; et
    comprend en outre une ou plusieurs entailles ou volets à l'extrémité avant de la gaine.
  12. Dispositif d'insertion selon la revendication 1, comprenant en outre un ou plusieurs mécanismes de rétroaction sélectionnés parmi le groupe comprenant audible, visible et tactile.
  13. Kit comprenant :
    le dispositif d'insertion (800, 1300, 1400) de l'une quelconque des revendications 1 à 12 ; et
    un dispositif intra-utérin positionnable dans la lumière distale de la gaine allongée.
EP12811921.1A 2011-07-11 2012-07-09 Systèmes intra-utérins, dispositifs d'introduction de dispositif intra-utérin (iud), et trousses pour ceux-ci Active EP2731562B2 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201161506434P 2011-07-11 2011-07-11
US13/539,843 US10028858B2 (en) 2011-07-11 2012-07-02 Intrauterine systems, IUD insertion devices, and related methods and kits therefor
PCT/US2012/045906 WO2013009674A2 (fr) 2011-07-11 2012-07-09 Systèmes intra-utérins, dispositifs d'introduction de dispositif intra-utérin (iud), et procédés associés et trousses pour ceux-ci

Publications (4)

Publication Number Publication Date
EP2731562A2 EP2731562A2 (fr) 2014-05-21
EP2731562A4 EP2731562A4 (fr) 2014-12-17
EP2731562B1 EP2731562B1 (fr) 2018-09-12
EP2731562B2 true EP2731562B2 (fr) 2022-08-10

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EP12811921.1A Active EP2731562B2 (fr) 2011-07-11 2012-07-09 Systèmes intra-utérins, dispositifs d'introduction de dispositif intra-utérin (iud), et trousses pour ceux-ci

Country Status (17)

Country Link
US (4) US10028858B2 (fr)
EP (1) EP2731562B2 (fr)
JP (1) JP2014523780A (fr)
KR (1) KR20140051296A (fr)
CN (1) CN104023681B (fr)
AP (1) AP2014007363A0 (fr)
AU (1) AU2012282832B2 (fr)
BR (2) BR112014000440B1 (fr)
CA (2) CA3099636C (fr)
CO (1) CO6920268A2 (fr)
EA (1) EA201490251A1 (fr)
ES (1) ES2694173T5 (fr)
GE (1) GEP20166482B (fr)
MX (1) MX357354B (fr)
PE (1) PE20142239A1 (fr)
WO (1) WO2013009674A2 (fr)
ZA (1) ZA201400225B (fr)

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US10028858B2 (en) 2018-07-24
CN104023681B (zh) 2016-08-31
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NZ619783A (en) 2016-03-31
JP2014523780A (ja) 2014-09-18
ZA201400225B (en) 2015-04-29
AU2012282832A1 (en) 2014-01-23
US20240415693A1 (en) 2024-12-19
CN104023681A (zh) 2014-09-03
US20130014762A1 (en) 2013-01-17
MX2014000405A (es) 2017-02-15
HK1201434A1 (en) 2015-09-04
EA201490251A1 (ru) 2014-06-30
WO2013009674A3 (fr) 2013-03-21
EP2731562A2 (fr) 2014-05-21
KR20140051296A (ko) 2014-04-30
WO2013009674A8 (fr) 2014-03-27
MX357354B (es) 2018-07-05
CA3099636A1 (fr) 2013-01-17
BR122015016218A2 (pt) 2019-08-27
US20180303660A1 (en) 2018-10-25
US11090186B2 (en) 2021-08-17
CA2841855C (fr) 2021-01-12
EP2731562B1 (fr) 2018-09-12
CA3099636C (fr) 2023-06-27
PE20142239A1 (es) 2015-01-08
CO6920268A2 (es) 2014-04-10
BR112014000440B1 (pt) 2021-05-25
GEP20166482B (en) 2016-05-25
ES2694173T5 (es) 2022-11-29
US20210393434A1 (en) 2021-12-23
ES2694173T3 (es) 2018-12-18
US12427053B2 (en) 2025-09-30
EP2731562A4 (fr) 2014-12-17
BR122015016218B1 (pt) 2021-03-09
CA2841855A1 (fr) 2013-01-17
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WO2013009674A2 (fr) 2013-01-17
BR112014000440A2 (pt) 2017-02-14

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